pulmonologyadvisor1d
Mepolizumab Under Review for Eosinophilic COPD
The FDA has accepted for review the BLA for mepolizumab as an add-on maintenance treatment for eosinophilic COPD.
FDA to review GSK’s Nucala for COPD
The US Food and Drug Administration (FDA) has accepted a submission from GSK to review a new indication of Nucala ...
Pharmabiz1d
US FDA accepts GSK’s submission for the use of Nucala to treat patients with chronic obstructive pulmonary disease
US FDA accepts GSK’s submission for the use of Nucala to treat patients with chronic obstructive pulmonary disease: London, UK Wednesday, December 11, 2024, 10:00 Hrs [IST] GSK ...
Hosted on MSN3d
FDA Accepts GSK's Filing for Expanded Use of Nucala in COPD
GSK plc GSK announced that the FDA has accepted its regulatory filing, seeking the approval of a new indication for Nucala (mepolizumab) in chronic obstructive pulmonary disease (COPD) treatment for ...
The Pharma Letter3d
FDA accepts GSK’s re-submission for Nucala
After previously rejecting an application for this indication, the US Food and Drug Administration (FDA) has now accepted for ...
Daily1d
USFDA accepts GSK submission for use of Nucala in COPD
London: GSK plc has announced the US Food and Drug Administration (FDA) has accepted for review, data from the MATINEE study ...
GSK: FDA Accepts For Review Submission For New Indication Of Nucala In COPD
British drug maker GSK plc (GSK, GSK.L) announced Monday that the U.S. Food and Drug Administration has accepted for review, data ...
pharmaphorum4y
GSK eyes nasal polyps use for Nucala after trial success
GlaxoSmithKline is eyeing another indication for its Nucala (mepolizumab) biologic drug after a phase 3 trial in inflammation caused by nasal polyps hit its targets, bringing it into competition ...
pharmaphorum7y
GSK seeks COPD approval for mepolizumab
GlaxoSmithKline has asked the US regulator to expand the licence of its injected lung drug mepolizumab, to include chronic obstructive pulmonary disease (COPD). Under the brand name Nucala ...
GSK announces U.S. FDA accepted its submission for use of Nucala in COPD
GSK (GSK) announced the US Food and Drug Administration, FDA, has accepted for review, data from the MATINEE study to support the regulatory ...
GSK says US agrees to look at data for new use of COPD drug
GSK said the US Food and Drug Administration has agreed to look at data from its MATINEE study to support the regulatory review process to obtain a new use of its Nucala drug as an add-on maintenance ...